Synthes Zero-P Variable Angle (Va)

Q: What is the product code of K112068?

The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.

FDA 510(k) K112068 · Synthes Spine Co.Lp

Substantially Equivalent

510(k) numberK112068

Submission

Device name: Synthes Zero-P Variable Angle (Va)
Applicant: Synthes Spine Co.Lp
West Chester, PA, US
Received: July 20, 2011
Decision date: November 7, 2011
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3080
Specialty: Orthopedic
Implant: Yes

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other 510(k)s with product code OVE

510(k)	Device	Applicant	Decision
K261882	Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional	Osseus Fusions Systems, LLC	08/21/2026SE
K261451	ZSAlign Cervical Interbody SystemOVE · Traditional	ZSFab, Inc.	07/31/2026SE
K262094	E3D-C Interbody SystemOVE · Special	Evolution Spine	07/22/2026SE
K261279	DeltaNEC Interbody SystemOVE · Traditional	Nexus Spine	06/22/2026SE
K252982	CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional	Avalign Technologies, Inc.	06/18/2026SE
K260036	NeckTune 3D SA Cervical CageOVE · Traditional	Medyssey Co, Ltd.	06/15/2026SE
K260660	SABER-C SystemOVE · Traditional	Elevation Spine	04/27/2026SE
K253213	SAGI Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/20/2026SE
K252774	Uni-C Cervical Cage SystemOVE · Traditional	ZheJiang Decans Medical Devices Co., Ltd.	04/15/2026SE
K260038	E3D-C Interbody SystemOVE · Special	Evolution Spine	02/04/2026SE

More from Evolution Spine

510(k)	Device	Decision
K122211	Synthes Navigable Pedicle Preparation InstrumentsHAW · Traditional	12/17/2012SE
K120838	Synthes Matrix SystemNKB · Traditional	07/31/2012SE
K121852	Synthes Zero-P Variable Angle (Va)OVE · Special	07/25/2012SE
K111048	Synthes Scout Tack FixationOMR · Traditional	06/14/2012SESU
K120928	Synthes Matrix SystemNKB · Traditional	05/18/2012SE
K120571	Synthes Uss ConnectorNKB · Traditional	05/14/2012SE
K113149	Synthes Uss ConnectorsMNI · Traditional	02/01/2012SE
K113044	Synthes MirsNKB · Traditional	12/21/2011SE
K112459	Synthes Zero-POVE · Special	12/12/2011SE
K111358	Synthes UssNKB · Traditional	11/18/2011SE

Questions and answers

When was Synthes Zero-P Variable Angle (Va) cleared by the FDA?

Synthes Zero-P Variable Angle (Va) (K112068) received a 510(k) decision of Substantially Equivalent on November 7, 2011, 110 days after the submission was received.

What is the product code of K112068?

The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.